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Company

Original Job Post

myGwork - LGBTQ+ Business Community · 2 days ago

Scientist II, Upstream or Downstream Process Development

Plainville, MA

Full-time

Onsite

Mid Level

3+ years exp

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Responsibilities

Contribute to process development and scale-up projects.

Act as a subject matter expert in upstream or downstream processes for viral vectors.

Lead training activities.

Prepare and modify development documents and reports.

Identify technical challenges and solutions for new processes.

Support analytical testing and data interpretation.

Qualification

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Experimental DesignLaboratory ExperimentsAnalytical DevelopmentTesting PlansProcess Development ReportsProcess Development RecordsWork InstructionsBatch RecordsDesign of ExperimentsDOE StudiesHigh-Throughput ScreeningsTechnical Writing Documentation PracticesData CompilationData InterpretationScientific Data PresentationProblem-SolvingCollaborationCommunicationFlexibilityAseptic TechniquesCell CultureSingle-Use BioreactorsWave ReactorsHarvest/Clarification ProcessesTransfectionInfection-Based ProcessesScaling Up/Downstream ProcessesPurification TechniquesAKTA Chromatography Systems

Required

B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ yrs, of experience or Master's degree.

Proven understanding of experimental design and the ability to independently conduct laboratory experiments.

Collaborate with the Analytical Development team to develop comprehensive testing plans.

Participate in client meetings to present results and assist with drafting process development reports.

Independently prepare or review Process Development records, work instructions, and batch records.

Design and conduct Design of Experiments (DOE) studies and high-throughput screenings tailored for either upstream or downstream process development.

Proficiency in technical writing, adhering to Good Documentation Practices (GDP), with preferred experience in data compilation and interpretation.

Strong communication skills with the ability to clearly and concisely interpret, summarize, and present scientific data.

Flexibility in work hours, including availability for weekends and evenings, as the need arises to meet project deadlines.

Preferred

Practical experience in aseptic techniques, cell culture, single-use bioreactors (SUBs), wave reactors, and harvest/clarification processes.

Familiarity with transfection and infection-based processes for gene therapy production.

Expertise in working with single-use stirred tank bioreactors.

Experience in scaling up and scaling down upstream processes for viral vectors or biologics.

Expertise in various purification techniques, including affinity and anion exchange chromatography, with proficiency in using AKTA chromatography systems and Unicorn software.

Extensive experience with filtration-based unit operations such as tangential flow filtration, sterile filtration, and depth filtration.

Familiarity with viral clearance processes.

Experience in scaling up and scaling down downstream processes for viral vectors or biologics.

Ability to analyze and summarize scientific data.

Understanding of GLP requirements of biopharmaceutical development.

Strong interpersonal and communications skills; written and oral.

Ability to function in a constantly evolving environment & prioritize multiple priorities.

A flexible work schedule is required including weekend and night as needed to support lab activities.

You may be required to support other VVS MA sites as needed.